Merus plans to report on interim data from patients whose cancer cells harbor NRG1 fusions at a medical conference by the end of 2020, when more mature data, better characterization of the patient population and activity ofMCLA-128 in a larger set of patients are expected to be available. Details of the eNRGy trial evaluating MCLA-128 in patients with NRG1 fusions, including current trial sites, can be found atClinicalTrials.gov and Merus’ trial website atnrg1.com.
MCLA-128 (HER3 x HER2 Biclonics®): Phase 2 Metastatic Breast Cancer interim analysis reported
In the Phase 2 Metastatic Breast Cancer trial, in patients enrolled as of August 31, 2019, Merus conducted an unplanned interim efficacy analysis with a datacut-off of October 23, 2019. The company expects to present mature results, including the primary endpoint of clinical benefit rate at 24 weeks for both cohorts at a medical conference in 2020. Following the planned completion of the Phase 2 Metastatic Breast Cancer Trial, Merus will only advance development in metastatic breast cancer or gastric cancer with a collaborator. Merus intends to focusMCLA-128 program efforts on the eNRGy trial going forward.
MCLA-117 (CLEC12A x CD3 Biclonics®): Expect to present initial Phase 1 data at a medical conference 1H 2020.
Merus remains on track to present initial data at a medical conference in the first half of 2020. In July 2019, Merus amended theMCLA-117 protocol to allow for the exploration of higher doses. The Phase 1 trial initiated at a low dose level based on the potent nature ofT-cell engagers. Preliminary anti-tumor activity was reported in December 2018 and dose escalation for the Phase 1 clinical trial forMCLA-117 continues.
MCLA-158 (Lgr5 x EGFR Biclonics®): Initial safety data from Phase 1 trial expected at end of 2019, further guidance in 2020
The dose escalation of the Phase 1 clinical trial ofMCLA-158 in patients with solid tumors is progressing as planned. Emerging data for the Phase 1 trial, which will include safety and information around the recommended Phase 2 dose, is expected at the end of 2019. Merus plans to provide further guidance on the program in 2020.
MCLA-145 (CD137 xPD-L1 Biclonics®): Phase 1 clinical trial progressing as planned
The Phase 1, open-label, single-agent clinical trial ofMCLA-145 is ongoing and consists of dose escalation followed by dose expansion. Preclinical data has demonstrated thatMCLA-145 has the potential to overcome known side effects of CD137 agonists currently in development. Merus is developingMCLA-145 as part of a collaboration with Incyte signed in December 2016 to potentially develop and commercialize up to 11 bispecific and monospecific antibodies from the Merus Biclonics® platform.
MCLA-129 (EGFR xc-MET Biclonics®):Pre-clinical data presented at medical conference October 2019
On October 29, 2019, Merus presentedpre-clinical data for the first time at theAACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.MCLA-129 is an antibody-dependent cell-mediated cytotoxicity (“ADCC”) -enhanced Biclonics® that inhibits the EGFR andc-MET signaling pathways in solid tumors. Preclinical data has shown thatMCLA-129 reverses resistance to tyrosine kinase resistantnon-small cell lung cancer (NSCLC) cell lines resulting in tumor growth inhibition in xenograft models of NSCLC.MCLA-129 is being developed in collaboration with Betta Pharmaceuticals (“Betta”), and is currently inIND-enabling studies. Under the collaboration entered into in December 2018, Merus granted an exclusive license to Betta to develop and commercializeMCLA-129 in China and Merus has retained all rights outside of China.
Third Quarter 2019 Financial Results
Total revenue for the three months ended September 30, 2019 was €8.1 million compared to €6.5 million for the same period in 2018. Revenue is comprised primarily of the amortization of upfront license payments, R&D cost